Method and system for wound care

ABSTRACT

In one aspect, the present invention relates to a wound-care assembly The wound-care assembly includes a base layer. A film layer is operatively coupled to the base layer and a fluid conductor is in fluid communication with a wound and a vacuum source. The wound-care assembly further includes a fiber-optic patch comprising a plurality of fiber-optic strands. The fiber-optic strands are pressed into contact with an interior surface of the wound by the fluid conductor. The fiber-optic patch provides ultraviolet light to the wound and the relative vacuum is applied to the wound via the vacuum source and the fluid conductor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and incorporates by reference forany purpose the entire disclosure of, U.S. Provisional PatentApplication No. 61/902,455, filed Nov. 11, 2013.

BACKGROUND

1. Field of the Invention

The present invention relates to a wound care method and system with oneor both of vacuum-light therapy, pulsed radio frequency (“RF”), andoxygenation, and more particularly, but not by way of limitation, toadaptive wound-care patch capable of being utilized in a variety ofwound locations where one or both of vacuum-light therapy, pulsed radiofrequency (“RF”), and oxygenation may be applied thereto.

2. History of the Related Art

An important aspect of patient treatment is wound care. Medicalfacilities are constantly in need of advanced technology for thecleaning and treatment of skin wounds. The larger the skin wound, themore serious the issues are of wound closure and infection prevention.The rapidity of the migration over the wound of epithelial andsubcutaneous tissue adjacent the wound is thus critical. Devices havebeen developed and/or technically described which address certainaspects of such wound healing. For example, U.S. Pat. No. 6,695,823 toLina et al. (“Lina”) describes a wound therapy device that facilitateswound closure. A vacuum pump is taught for collecting fluids from thewound. WO 93/09727 discloses a solution for wound drainage by utilizingnegative pressure over the wound to promote the above referencesmigration of epithelial and subcutaneous tissue over the wound.

In other embodiments, wound treatment is performed using light therapy.For example, U.S. Pat. No. 7,081,128 to Hart et al. (“Hart”) describes amethod of treating various medical conditions such as, for example,joint inflammation, edema, etc., utilizing an array of Light EmittingDiodes contained on a flexible substrate that may be wrapped around ananatomical feature of the human body. U.S. Pat. No. 6,596,016 to Vremanet al. (“Vreman”) discloses a phototherapy garment for an infant havinga flexible backing material, a transparent liner, and a flexible printedcircuit sheet containing surface-mounted LEDs. The LEDs preferably emithigh-intensity blue light, suitable for the treatment of neonatalhyperbilirubinemia. The device may include a portable power supply.

In other embodiments, wound treatment is performed using oxygen. The useof oxygen for the treatment of skin wounds has been determined to bevery beneficial in certain medical instances. The advantages aremultitudinous and include rapidity in healing. For this reason, systemshave been designed for supplying high concentration of oxygen to woundsites to facilitate the healing process. For example, U.S. Pat. No.5,578,022 to Scherson et al. (“Scherson”) teaches an oxygen producingbandage and method. One of the benefits cited in Scherson is the abilityto modulate a supply of concentrated hyperbaric oxygen to skin wounds.Although oxygen is beneficial in direct application of predetermineddosages to skin wounds, too much oxygen can be problematic. Oxygenapplied to a wound site can induce the growth of blood vessels forstimulating the growth of new skin. Too much oxygen, however, can leadto toxic effects and the cessation of healing of the wound. It would bean advantage, therefore, to maximize the effectiveness of oxygen appliedto a wound area by enhancing the absorption rate of oxygen into the skinand tissue fluids. By enhancing the absorption rate of the oxygen in thewound, less exposure time and concomitantly fewer toxic side effects tothe endothelial cells surrounding the wound, such as devasculation,occurs. It would be a further advantage, therefore, to utilize existingmedical treatment modalities directed toward other aspects of patienttherapy to augment oxygenation for wound care.

SUMMARY

The present invention relates generally to a wound care method andsystem with one or both of vacuum-light therapy, pulsed radio frequency(“RF”), and oxygenation, and more particularly, but not by way oflimitation, to adaptive wound-care patch capable of being utilized in avariety of wound locations where one or both of vacuum-light therapy,pulsed radio frequency (“RF”), and oxygenation may be applied thereto.

In one aspect, the present invention relates to a wound-care assemblyThe wound-care assembly includes a base layer. A film layer isoperatively coupled to the base layer and a fluid conductor is in fluidcommunication with a wound and a vacuum source. The wound-care assemblyfurther includes a fiber-optic patch comprising a plurality offiber-optic strands. The fiber-optic strands are pressed into contactwith an interior surface of the wound by the fluid conductor. Thefiber-optic patch provides ultraviolet light to the wound and therelative vacuum is applied to the wound via the vacuum source and thefluid conductor.

In another aspect, the present invention relates to a method ofutilizing a wound-care assembly. The method includes applying afiber-optic patch to a wound. The fiber-optic patch is pressed intocontact with an inner surface of the wound via a fluid conductor. Thefluid conductor and the fiber-optic patch are secured to the wound. Avacuum applicator is applied to and secured to the fluid conductor.Ultraviolet light is applied to the wound via the fiber-optic patch anda relative vacuum is applied to the wound via the fluid conductor.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and forfurther objects and advantages thereof, reference may now be had to thefollowing description taken in conjunction with the accompanyingdrawings in which:

FIG. 1A is a top view of a wound-care patch according to an exemplaryembodiment;

FIG. 1B is an exploded view of the wound-care patch of FIG. 1A accordingto an exemplary embodiment;

FIG. 1C is a perspective view of the wound-care patch of FIG. 1Aaccording to an exemplary embodiment;

FIG. 2 is a bottom view of the wound-care patch of FIG. 1 according toan exemplary embodiment;

FIG. 3 is a flow diagram of a method for using the wound-care patch ofFIG. 1 according to an exemplary embodiment;

FIG. 4A is a top view of a package containing a wound-care assemblyaccording to an exemplary embodiment;

FIG. 4B is a an exploded view of the wound-care assembly of FIG. 4A;

FIG. 5A is a bottom view of the wound-care assembly of FIG. 4 applied toa foot according to an exemplary embodiment;

FIG. 5B is a top view of the wound-care assembly of FIG. 4 applied to afoot according to an exemplary embodiment; and

FIG. 6 is a flow diagram of a method for using the wound-care patch ofFIG. 4 according to an exemplary embodiment.

DETAILED DESCRIPTION

Various embodiments of the present invention will now be described morefully with reference to the accompanying drawings. The invention may,however, be embodied in many different forms and should not be construedas limited to the embodiments set forth herein.

FIG. 1 is a top view of a wound-care patch 100. The wound-care patch 100includes a base layer 102 that is coupled to a film layer 104. In atypical embodiment, the base layer 102 is constructed of a sterile,ethylyne-oxide, biocompatible material. The film layer 104 is, in atypical embodiment, constructed from, for example, medical gradepolyurethane. A peripheral edge 106 of the film layer 104 is secured toa corresponding edge of the base layer 102 through a process such as,for example, welding. Connection of the film layer 104 to the base layer102 creates a seal around the peripheral edge 106, which seal preventsleakage of fluid therefrom. A fluid port 114 is formed in the film layer104.

Still referring to FIG. 1, a fluid conductor 108 is disposed between thebase layer 102 and the film layer 104. In a typical embodiment, thefluid conductor 108 is flexible, absorptive, and constructed of, forexample, medical grade foam. The fluid conductor includes awound-treatment portion 110 disposed proximate a wound (not shown inFIG. 1) and a straw portion 112 that fluidly couples the wound-treatmentportion 110 to the fluid port 114. In a typical embodiment, the fluidconductor 108 transmits fluids such as, for example, liquids or gases,from the wound to the fluid port 114 and, thus, allows a vacuum to beapplied to the wound via the fluid port 114. In addition, the strawportion 112 facilitates placement of the fluid port 114 at a locationremoved from the wound. Such an arrangement is beneficial if, forexample, space constraints do not allow the fluid port 114 to be placednear the wound.

Still referring to FIG. 1, a fiber-optic cable 116 is coupled to thewound-care patch 100. A plurality of fiber-optic strands 118 extend fromthe fiber-optic cable 116. The fiber-optic strands are disposed betweenthe base layer 102 and the film layer 104 and are arranged in agenerally flat, side-by-side configuration. The fiber-optic strands 118are disposed beneath the fluid conductor 108.

FIG. 1B is an exploded view of the wound-care patch 100. FIG. 1C is aperspective view of the wound-care patch 100. FIG. 2 is a bottom view ofthe wound-care patch 100. Referring to FIGS. 1B-2 together, a window 120is formed in a bottom face of the base layer 102. The fiber-opticstrands 118 extend across the window 120. The wound-treatment portion110 of the fluid conductor 108 (shown in FIG. 1A) is disposed over thewindow 120 above the fiber-optic strands 118. In a typical embodiment,the wound-care patch 100 is arranged such that the window 120 ispositioned over the wound. A mesh 121 extends across the window 120below the fiber-optic strands 118. In a typical embodiment, the mesh 121prevents adhesion of wound tissue to either the fiber-optic strands 118or the fluid conductor 108. A biocompatible skin adhesive (not shown)such as, for example, Tegaderm™, manufactured by 3M Company (hereinafter“Tegaderm”), is used to secure the edges of the wound-care patch 100 toskin surrounding the wound.

During operation, a vacuum pump (not explicitly shown) is coupled to thefluid port 114. Such an arrangement allows a relative vacuum to beapplied to the wound via the fluid conductor 108. In addition, a sourceof ultra-violet light (not explicitly shown) is coupled to thefiber-optic strands 118. The ultra-violet light is emitted from thefiber-optic strands 118 into the wound. The ultraviolet light emittedfrom the fiber-optic strands 118 may be modulated to create variouspatterns of light, different intensities of light, and differentdurations of light such as , for example, pulsed emission of ultravioletlight. The ultraviolet light is capable of penetrating through severallayers of skin to destroy infectious bacteria. According to exemplaryembodiments, the ultraviolet light from fiber-optic strands 118 destroysa wide variety of microorganisms such as, for example, bacteria whichcauses skin infections. In addition, the ultraviolet light from thefiber-optic strands 118 improves wound healing along with cell and bonegrowth. Furthermore, the use of ultraviolet light in light therapy issafe, non-invasive, drug-free and therapeutic.

Still referring to FIGS. 1C-2, in various embodiments, a therapeuticagent, such as, for example, concentrated oxygen may be applied to thewound site via the port 114. In such embodiments, the port 114 mayinclude two parallel lumen couplings to facilitate alternatingapplication of the therapeutic agent and the relative vacuum. In variousembodiments, the therapeutic agent may be thermally augmented prior toapplication to the wound area. In other embodiments, the therapeuticagent is not thermally augmented. Still referring to FIGS. 1C-2, invarious embodiments, a radio frequency (“RF”) antenna 122 is disposedaround the window 120. In a typical embodiment, the RF antenna 122comprises a wire 124. The wire 124 extends around a perimeter of thewindow 120. In a typical embodiment, the wire 124 is disposed such that,during use, the wire 124 is in close proximity to the wound. In variousembodiments, the wire 124 is insulated to reduce risk of electric shockto a patient.

Still referring to FIGS. 1C-2, during operation, a pulsedradio-frequency (“RF”) signal having a pulse frequency on the order of,for example 27 MHz, is transmitted to the RF antenna 122. In a typicalembodiment, an amplitude of the pulsed RF signal is on the order of, forexample, a fraction of a Watt. Such an amplitude is below a thresholdwhere federal licensing is typically required. The RF antenna 122receives the pulsed RF signal from a radio-frequency source andtransmits the pulsed RF signal to a region in close proximity to thewound. Exposing the wound to the pulsed RF signal has been shown to bebeneficial to healing by encouraging intracellular communication. Inparticular, pulsed RF signals have been shown to stimulate cellularbonding, and metabolism.

FIG. 3 is a flow diagram of a process 300 for using the wound-care patch100. The process 300 begins at step 302. At step 304, the wound-carepatch 100 is applied to a wound. At step 306, a biocompatible skinadhesive is used to secure the edges of the wound care patch 100 to apatient's skin surrounding the wound. At step 308, the fluid port 114 iscoupled to a vacuum source and the fiber-optic cable 116 is connected toan ultraviolet light source. At step 310, a relative vacuum is appliedto the fluid port 114. The relative vacuum is transmitted to the woundvia the fluid conductor 108. In various embodiments, the relative vacuumfacilitates removal of undesirable tissues from the wound such as, forexample, dead tissue and foreign contaminants. In addition, the relativevacuum draws out fluid from the wound thereby increasing blood flow intothe wound area. At step 312, ultraviolet light is supplied to the woundvia the fiber-optic cable 116 and the fiber-optic strands 118. In atypical embodiment, the ultraviolet light is supplied to the wound areasimultaneous with the application of the relative vacuum. In otherembodiments, at least one of the ultraviolet light and the relativevacuum may be modulated or applied in various patterns and, thus, maynot be simultaneous. The process 300 ends at step 314.

FIG. 4A is a top view of a package 401 containing a wound-care assembly400. FIG. 4B is an exploded view of the wound-care assembly 400.Referring to FIGS. 4A and 4B together, the wound-care assembly 400includes a fiber-optic patch 402. The fiber-optic patch includes aplurality of fiber-optic strands 404. In a typical embodiment, theplurality of fiber-optic strands 404 are arranged in a generally flatside-by-side arrangement. The plurality of fiber-optic strands 404 areoptically coupled to a fiber-optic cable 406. In a typical embodiment,the fiber-optic cable 406 is optically connectable to a source ofultraviolet light. The wound-care assembly 400 further includes a vacuumapplicator 408. The vacuum applicator 408 includes a base layer 412 anda film layer 414. A fluid port 410 is formed in the film layer 414. Afluid conductor 416 is disposed beneath the fluid port 410 between thefilm layer 414 and the base layer 412. In a typical embodiment, thefluid conductor 416 is flexible, absorptive, and constructed of, forexample, medical grade foam. In a typical embodiment, the fluid port 410is connectable to a vacuum source. In a typical embodiment, the package401 maintains the wound-care assembly in a sterile environment untiluse.

Still referring to FIGS. 4A and 4B, an RF layer 403 is disposed abovethe fiber-optic patch 402. The RF layer 403 includes an antenna 405embedded therein. In a typical embodiment, the antenna 405 forms a looparound the wound. During operation, a pulsed radio-frequency (“RF”)signal having a pulse frequency on the order of, for example 27 MHz, istransmitted to the antenna 405. In a typical embodiment, an amplitude ofthe pulsed RF signal is on the order of, for example, a fraction of aWatt. Such an amplitude is below a threshold where federal licensing istypically required. The antenna 405 receives the pulsed RF signal from aradio-frequency source and transmits the pulsed RF signal to a region inclose proximity to the wound. Exposing the wound to the pulsed RF signalhas been shown to be beneficial to healing by encouraging intracellularcommunication. In particular, pulsed RF signals have been shown tostimulate cellular bonding, and metabolism.

FIG. 5A is a bottom view of the wound-care assembly 400 applied to afoot 502 of a patient. FIG. 5B is a top view of the wound-care assembly400 applied to a foot 502 of a patient. As illustrated in FIGS. 5A-5B awound 504 is present on the foot 502. The wound 504 is illustrated byway of example in FIG. 5 as being present on the foot 502; however, inother embodiments, the wound 504 may be disposed on any bodily region ofthe patient. The fiber-optic patch 402 is positioned over the wound 504in such a manner that the fiber-optic strands 404 extend across a widthof the wound 504. A fluid conductor 506 is shaped to approximately matcha shape of the wound 504. In a typical embodiment, the fluid conductor506 is flexible, absorptive, and constructed of, for example, medicalgrade foam. The fluid conductor 506 may cut or otherwise shaped toapproximately match a size and shape of the wound 504. The fluidconductor 506 is positioned above the fiber-optic patch 402 and presseddownwardly into the wound 504 thereby pressing the fiber-optic strands404 into contact with an interior surface of the wound 504. In variousembodiments, a straw portion 508 may be fluidly coupled to the fluidconductor 506. In a typical embodiment, the straw portion 508 isconstructed from a material similar to that of the fluid conductor 506.The straw portion 508 allows a relative vacuum to be applied to thewound 504, via the vacuum applicator 408, when the fluid port 410 isdisposed a location remote to the wound 504 such as, for example, on atop of the foot 502. Such an arrangement is advantageous in situationswhere the wound 504 is located in a space-confined area such as, forexample, a bottom of the patient's foot 502. The fiber-optic patch 402,the fluid conductor 506, and the straw portion 508 are secured in placevia a biocompatible skin adhesive such as, for example, tegaderm.

Still referring to FIGS. 5A-5B, a small hole is formed in thebiocompatible skin adhesive at a location where the vacuum applicator408 is to be applied. In various embodiments, the vacuum applicator 408is applied above the fluid conductor 506; however, in other embodiments,the vacuum applicator 408 may be applied to the straw portion 508. Thevacuum applicator 408 is secured via a biocompatible skin adhesive suchas, for example, tegaderm. In a typical embodiment, the wound-careassembly 400 facilitates flexible and modular construction for use on awide variety of bodily areas and wound types.

FIG. 6 is a flow diagram of a process 600 for using the wound-care patch400. The process 600 starts at step 602. At step 604, the fiber-opticpatch 402 is placed over the wound 504. At step 606, the fluid conductor506 is sized to approximately match a size and shape of the wound 504.At step 608, the fluid conductor 506 is pressed into the wound 504 abovethe fiber-optic patch 402. The fluid conductor 506 presses thefiber-optic strands 404 into contact with an inner surface of the wound504. At step 610, a straw portion 508 is constructed in fluidcommunication with the fluid conductor 506. At step 612, the fiber-opticpatch 402, the fluid conductor 506, and the straw portion 508 aresecured with a biocompatible skin adhesive such as, for example,tegaderm. At step 614, the vacuum applicator is applied to at least oneof the straw portion 508 or the fluid conductor 506.

Still referring to FIG. 6, at step 616, the fiber-optic cable 406 isconnected to a source of ultraviolet light and the vacuum applicator 408is fluidly coupled to a vacuum source. At step 618, a relative vacuum isapplied to the wound 504 via the vacuum applicator 408, the fluidconductor 506, and, in some embodiments, the straw portion 508. Invarious embodiments, the relative vacuum facilitates removal undesirabletissues from the wound 504. At step 620, ultraviolet light is applied tothe wound 504 via the fiber-optic cable 406, the fiber-optic patch 402,and the fiber-optic strands 404. In a typical embodiment, theultraviolet light is supplied to the wound 504 simultaneous with theapplication of the relative vacuum. In other embodiments, at least oneof the ultraviolet light and the relative vacuum may be modulated orapplied in various patterns and, thus, may not be simultaneous. Theprocess 600 ends at step 622.

Although various embodiments of the method and system of the presentinvention have been illustrated in the accompanying Drawings anddescribed in the foregoing Specification, it will be understood that theinvention is not limited to the embodiments disclosed, but is capable ofnumerous rearrangements, modifications, and substitutions withoutdeparting from the spirit and scope of the invention as set forthherein. It is intended that the Specification and examples be consideredas illustrative only.

What is claimed is:
 1. A wound-care assembly comprising: a base layer; afilm layer operatively coupled to the base layer; a fluid conductor influid communication with a wound and a vacuum source; a fiber-opticpatch comprising a plurality of fiber-optic strands, the fiber-opticstrands being pressed into contact with an interior surface of the woundby the fluid conductor; wherein the fiber-optic patch providesultraviolet light to the wound; and wherein a relative vacuum is appliedto the wound via the vacuum source and the fluid conductor.
 2. Thewound-care assembly of claim 1, comprising a fluid port fluidly coupledto the fluid conductor.
 3. The wound-care assembly of claim 2, whereinthe fluid conductor comprises a straw portion that facilitates placementof the fluid port at a location distal to the wound.
 4. The wound-careassembly of claim 2, wherein a therapeutic agent is applied to the woundvia the fluid port.
 5. The wound-care assembly of claim 4, wherein thetherapeutic agent is thermally augmented.
 6. The wound-care assembly ofclaim 1, wherein the fiber-optic strands are arranged in a flat,side-by-side, configuration.
 7. The wound-care assembly of claim 1,comprising a window formed in the base layer, the window facilitatingfluid communication between the wound and the fluid conductor.
 8. Thewound-care assembly of claim 7, comprising a mesh extending across thewindow.
 9. The wound-care assembly of claim 7, comprising aradio-frequency (RF) antenna disposed around a circumference of thewindow.
 10. The wound-care assembly of claim 1, wherein the fluidconductor facilitates reduction of pressure at the wound from ambientpressure.
 11. A method of utilizing a wound-care assembly, the methodcomprising: applying a fiber-optic patch to a wound; pressing thefiber-optic patch into contact with an inner surface of the wound via afluid conductor; applying a vacuum applicator to the fluid conductor;applying ultraviolet light to the wound via the fiber-optic patch; andapplying a relative vacuum to the wound via the fluid conductor.
 12. Themethod of claim 11, comprising securing the fluid conductor and thefiber-optic patch to the wound.
 13. The method of claim 11, comprisingapplying a therapeutic agent to the wound via the fluid conductor. 14.The method of claim 13, comprising thermally augmenting the therapeuticagent.
 15. The method of claim 11, comprising applying a pulsedradio-frequency (RF) signal to the wound area via a radio-frequencyantenna.
 16. The method of claim 11, wherein the applying ultravioletlight comprises modulating the applied ultraviolet light.
 17. The methodof claim 11, wherein the applying a relative vacuum comprises fluidlycoupling the vacuum applicator to a straw portion of the fluid conductorat a location distal to the wound.
 18. The method of claim 11,comprising shaping the fluid conductor to approximately match a size anda shape of the wound.
 19. The method of claim 11, wherein the applying arelative vacuum to a wound facilitates removal of undesirable materialsfrom the wound.
 20. The method of claim 11, wherein the fiber-opticpatch comprises fiber-optic strands arranged in a flat side-by-sideconfiguration.